Structural support incorporating multiple strands

ABSTRACT

A fabricated component for providing desired structural support has plural strands of material extending between opposing gathering points, and free ends extending from the gathering points. The component is preferably fabricated from a single strand of material using an appropriate folding procedure which includes the formation of plural loops of the strand, one upon the other, and development of the gathering points in opposing regions of the looped strand by passing opposing ends of the strand around the loops of the strand, and then through the resulting throws, or using a separate knotting arrangement. The fabricated component can be used in medical procedures, such as the support of subcutaneous tissue, muscle and organs, and other non-medical applications.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority from U.S. patent application Ser. No.13/815,666, entitled “Structural Support Incorporating MultipleStrands”, filed on Mar. 13, 2013, the entire contents of which areincorporated by reference herein.

BACKGROUND OF THE INVENTION

The present invention generally relates to a fabricated componentcapable of use in supporting structural elements. The description whichfollows is primarily directed to uses of the fabricated component tosupport subcutaneous tissue, muscle and organs. It is to be understood,however, that the fabricated component is also capable of use insupporting various other structural elements.

Various devices have been proposed for use in supporting subcutaneoustissue, muscle and organs, particularly in applications where low stressis required to prevent damage or erosion of the engaged structures. Asan example, in face lift procedures, tissue-supporting slings have beenmade using woven or braided components, primarily formed of suturematerials. In practice, however, such devices have been unacceptable dueto their bulk and stiffness, which could be annoying to a patient.Moreover, because such devices are generally formed from a single strandof suture material, such devices have also been of concern because ofthe possibility of an erosion of such devices through tissue (i.e., aso-called “cheese-wire” effect).

Other proposed devices include barbs along a strand of suture materialto provide additional support by engaging the tissue at one or morelocations along the resulting component. In practice, however, suchdevices have also been troublesome because the barbs can pull away andcan also feel prickly under the skin.

Pledgets have also been proposed for use in supporting internal organsbut, in practice, are generally too bulky for use in supportingsubcutaneous tissues, particularly facial tissues. Pledgets are alsogenerally too large to be passed through small punctures in the skin andwould, therefore, require open surgery for insertion.

BRIEF SUMMARY OF THE INVENTION

In accordance with the present invention, these and other disadvantagesare overcome by providing a multi-stranded component for providingdesired structural support.

In a preferred embodiment, the multi-stranded component of the presentinvention has plural strands of material extending between opposinggathering points, and free ends extending from each of the gatheringpoints. The plural strands of material preferably freely extend betweenthe opposing gathering points so at least portions of the plural strandsare brought into contact with one another. The free ends are eachpreferably formed of a single strand of material and are made suitablefor desired manipulation in otherwise conventional manner. For use inapplications such as the support of subcutaneous tissue, muscle andorgans, the strands are preferably formed of suture materials useful inmedical procedures, including metallic materials. Strands formed ofother materials can be used in other, non-medical applications.

The multi-stranded component of the present invention can be fabricatedin any of a variety of ways to suit any of a variety of desiredapplications. As is presently considered preferred, however, themulti-stranded component is fabricated from a single strand of suturematerial using an appropriate folding procedure. One such foldingprocedure includes the formation of plural loops of the strand, one uponthe other. Opposing regions of the looped strand are then provided withgathering points, preferably by passing opposing ends of the strandaround the loops, in each case forming at least one throw, and thenthrough each of the resulting throws. As an alternative, themulti-stranded component can be fabricated from plural strands of suturematerial, once again using an appropriate folding procedure. One suchfolding procedure includes the formation of plural loops, one upon theother, with a first strand. Opposing regions of the looped strand arethen provided with gathering points, preferably by tying additionalstrands of suture material around the loops.

The gathering points are preferably formed so that the engaged strandscan slip within the gathering points, to allow the plural strands toslide relative to one another and to better conform to the shape of aregion to be engaged. The gathering points can be drawn down, forming aclosed loop structure, or can be tied off to form an open loop structureto facilitate sliding of the engaged strands relative to one another andrelative to the gathering points. This can be used to develop openthrows which can facilitate slippage of the engaged strands within thegathering points, to in turn facilitate sliding of the plural strandsrelative to one another.

The multi-stranded section can preferably adapt to the geometry of anengaged structure, including both curved and flat subcutaneous surfaces.Following fabrication, the plural strands extending between thegathering points will typically have a length corresponding to theregion to be engaged, and will preferably become equally taut, fordistribution of the load along the region to be engaged, such as tissue,muscle or an organ for the example of a medical procedure. This isparticularly useful in the engagement of weak tissue. The ends of thefabricated component are preferably single-stranded, and are well suitedto desired manipulations. The gathering points will be relatively small,and are well suited to passing through small structures and puncturepoints, and are easily tolerated because they are not bulky and are notsharp.

Such fabrication is sufficiently simple to allow the component to befabricated without the need for special fasteners, and the resultingassembly cannot unravel during use. Using an assembly made of acontiguous strand, or plural strands of material prevents the assemblyfrom breaking apart during use, or upon entry and removal. Thefabricated component can be provided with features that can be locatedwhen hidden from view, and which can be referenced to other structuresthat may be hidden from view, for example, to bone, teeth or softtissues in surgical applications.

Further description of the fabricated component, methods for fabricatingthe component, and uses of the fabricated component to support desiredstructures, is provided below, with reference to the following drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of an example of a fabricated component producedin accordance with the present invention.

FIG. 2 is a plan view of a strand prior to the fabrication of acomponent produced in accordance with the present invention.

FIG. 3 is a plan view of the strand of FIG. 2, provided with a coiledportion during fabrication.

FIG. 4 is a plan view of the coiled strand shown in FIG. 3, providedwith gathering points forming a closed loop at opposing regions of thecoiled portion during fabrication.

FIG. 5 is a plan view of the coiled strand shown in FIG. 3, providedwith gathering points forming an open loop at opposing regions of thecoiled portion during fabrication.

FIG. 6 is a plan view showing a fabricated component similar to thefabricated component shown in FIG. 5, which is formed from pluralstrands.

FIG. 7 shows an alternative embodiment fabricated component produced inaccordance with the present invention, with gathering points forming aclosed loop structure.

FIG. 8 shows the alternative embodiment fabricated component shown inFIG. 7, with gathering points forming an open loop structure.

FIG. 9 is a plan view of an alternative embodiment strand forfabricating the components shown in FIGS. 7 and 8, having a plurality ofknots formed in the strand.

FIG. 10 is a plan view of the strand of FIG. 9, provided with a coiledportion during fabrication.

FIG. 11 is a plan view of a further alternative embodiment fabricatedcomponent produced in accordance with the present invention, withgathering points forming a closed loop structure.

FIG. 12 shows the alternative embodiment fabricated component shown inFIG. 11, with gathering points forming an open loop structure.

FIG. 13 is a plan view showing an intermediate step in the process forfabricating the alternative embodiment components shown in FIGS. 11 and12.

FIG. 14 is a plan view showing a subsequent step in the process forfabricating the alternative embodiment components shown in FIGS. 11 and12.

FIGS. 15 and 16 are plan views of further alternative embodimentfabricated components produced in accordance with the present invention,provided with plural gathering points formed at opposing regions of thecoiled portion during fabrication.

FIGS. 17 to 19 are schematic views showing an application of thealternative embodiment components shown in FIGS. 5, 8 and 12,respectively, in situ.

FIG. 20 is a schematic view showing use of the alternative embodimentcomponent shown in FIG. 5 to support a duct, vessel or organ, in situ.

FIGS. 21 to 24 are schematic views illustrating modification of afabricated component produced in accordance with the present inventionto adjust the length of a fabricated component, in situ.

FIGS. 25 and 26 are side elevational views showing alternativetechniques for adjusting the length of a fabricated component producedin accordance with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows what is presently considered to be a preferred embodimentof the fabricated component 1 of the present invention. In thisconfiguration, the center portion 2 of the component 1 is comprised of aplurality of strands 3 ₁, 3 ₂, 3 ₃, 3 ₄ and 3 ₅. In the configurationselected for illustration in FIG. 1, a series of five strands 3 _(n) hasbeen employed. However, as will be understood from the discussion whichis to follow, the center portion 2 can have any number of strands 3_(n), as preferred for a particular application. As an example, and formedical applications, a center portion having up to ten strands 3 _(n)is presently considered to be preferred. The number of strands 3 _(n)used in a particular application is preferably limited to the size ofany openings or other structures through which the resulting component 1is to pass.

The strands 3 _(n) are each engaged by and extend between an opposingpair of gathering points 5 a, 5 b, and a free end 6, 7 extends from eachof the gathering points 5 a, 5 b, as shown. Each of the gathering points5 a, 5 b preferably encircles a plurality of loops, as will be describedmore fully below, for stabilizing the fabricated component, andpreferably bundles the strands and the plurality of loops together. Tothis end, the gathering points 5 a, 5 b are preferably tied together, ineach case forming a knot, or a plurality of knots, if appropriate for aparticular application. The resulting knot preferably allows the pluralstrands 3 _(n) to slip relative to one another and relative to thegathering points 5 a, 5 b, although fixed knots can also be used, ifdesired for a particular application. Knots useful for such purposes canbe formed using a single throw, or multiple throws, as preferred, andthe plural strands 3 _(n) can have any of a variety of desired lengths.Plural strands 3 _(n) having lengths on the order of 0.5 cm to 5 cm arepresently considered preferred for medical/surgical applications such astissue or muscle lifting or organ positioning.

Fabrication of the component 1 shown in FIG. 1 will now be describedwith reference to FIGS. 2 to 4. Referring to FIG. 2, a strand 8 formedof a suitable material is provided, prior to fabrication. To facilitatefabrication and to prevent the resulting component 1 from separatingduring use, a unitary strand 8 is preferably used. As alternatives, thestrand can be formed from a plurality of suitably joined strandsections, and multiple, preferably contiguous strands can be usedinstead of the single strand illustrated in FIG. 2. The strand 8 can beformed of any of a variety of suitable materials, which will depend onthe application anticipated for the component 1 being fabricated. As anexample, a conventionally available suture material is advantageouslyused in medical applications.

Referring next to FIG. 3, central portions 9 of the strand 8 areinitially formed into a plurality of loops or coils 10 _(n), including ahalf-section 13 for completion of the desired assembly as will bediscussed more fully below. The coils 10 _(n) can be round or oval ingeneral shape, and can be formed with as many turns as is desired for aparticular application. Two coils 10 _(n), including the half-section 13for completion of the assembly, have been selected for illustration forpurposes of forming the series of five strands 3 ₁, 3 ₂, 3 ₃, 3 ₄, 3 ₅shown in FIG. 1. It is to be understood, however, that other numbers ofcoils 10 _(n), for developing other numbers of strands 3 _(n), can beused either in the configuration shown in FIG. 1, or in other desiredconfigurations. In any event, the major diameter of the coiled loopswill determine the length of the resulting, multi-stranded centerportion 2.

Referring now to FIG. 4, each of the gathering points 5 a, 5 b is thenformed to complete fabrication of the component 1. This is preferablydone by passing the opposing ends 6, 7 of the strand 8 around the bundleof coils 10 _(n), in each case forming a throw 11, and by then passingthe free ends 6, 7 of the strand 8 through each of the resulting throws11, to hold the coils 10 _(n) together. As an alternative, separatestrands of material can be passed around the bundle of coils 10 _(n) tohold the coils 10 _(n) together, which can be used to develop free ends6, 7 having a plurality of strands, if desired. Free ends 6, 7 having aplurality of strands can also be developed using a strand 8 formed frommultiple strands, as previously described. As a further alternative, thefree ends 6, 7 can be provided with loops, or looped portions, tofacilitate the subsequent tying procedures which will be more fullydescribed below, as well as broadened features, such as knots or beads,which can be used to provide support for the fabricated component whichis normal to the ends 6, 7, when connected to desired attachment points.As a result, the lift axis established by the connected ends 6, 7 can beplaced substantially normal to the supporting structure.

Each knot 12 resulting from the foregoing procedure is preferably tiedto allow the plural strands 3 _(n) to slide relative to one another andrelative to the tied gathering points 5 a, 5 b. As a result, and whenstretched by forces F_(a) and F_(b), the strands 3 _(n) are allowed toslip into equal lengths, and the knots 12 are tightened to organized thestrands 3 _(n) into a suitably clustered array or web. In this way, thestrands 3 _(n) are provided with an equivalent length well suited to theequal support of a desired load. If, however, the support surface isslightly uneven, or warped, the lengths of the strands 3 _(n) canreadily adjust to such unevenness by sliding through the knots 12. Aslong as opposing forces are maintained, the resulting cluster willmaintain its shape without unraveling. As an alternative, and ifpreferred for a particular application, an adhesive can be applied tothe cluster, preferably at each of the knots 12, or a fixed knot can beused to maintain the resulting assembly in its desired configuration.Virtually any suture, string, cord, rope, metal component, or otherstrand, can be formed in this configuration.

In the configuration shown in FIG. 1, the knots 12 are drawn down,causing the throws 11 to contract into a closed loop structure whichclosely surrounds the engaged coils 10 _(n) at each of the gatheringpoints 5 a, 5 b. As an alternative, and referring to FIG. 5, the knots12′ can be tied off, as shown, to develop throws 11′ forming a component1′ with an open loop structure having knots 12′ spaced from the coils 10_(n). Providing throws 11′ forming an open loop structure is presentlyconsidered preferred to facilitate sliding of the plural strands 3 _(n)relative to one another and relative to the gathering points 5 a, 5 b.As a result, when stretched by forces F_(a) and F_(b), the strands 3_(n) are allowed to more easily slip into the equal lengths preferred toprovide the strands 3 _(n) with an equivalent length well suited to theequal support of a desired load.

In the configurations shown in FIGS. 1 and 5, a unitary strand 8 is usedto form the plurality of coils 10 _(n), the gathering points 5 a, 5 b,and the free ends 6, 7. As a further alternative, multiple strands canbe used to form the component 1″ shown in FIG. 6. In this configuration,a first strand 8′ similar to the strand 8 shown in FIGS. 1 and 5 isinitially formed into a plurality of loops or coils 10 _(n), similar tothe coils 10 _(n) shown in FIGS. 1 and 5 except that the half-section 13is no longer needed for completion of the desired assembly. The ends ofthe first strand 8′ are then knotted, at 14, to complete the coils 10_(n). Additional strands 8″, 8′″ formed of suitable materials, which canbe the same material as the strand 8′, or different materials, ifpreferred, are then used to form the opposing gathering points 5 a, 5 b,and the free ends 6, 7 extending from the gathering points 5 a, 5 b, asshown. Knots 12′ can be used to form the open loop structures shown inFIG. 6, or the gathering points 5 a, 5 b can be drawn down to formclosed loop structures, as desired. The fabricated component 1″ shown inFIG. 6 is otherwise substantially similar to the fabricated components1, 1′ shown in FIGS. 1 and 5.

As a result of the foregoing, the plural strands 3 _(n) will freelyextend between the opposing gathering points 5 a, 5 b so that at leastportions of the plural strands 3 _(n) are brought into contact with oneanother. This is presently considered preferred to provide additionalstress distribution along the center portion 2 of the fabricatedcomponent, for example, to provide additional stress distribution alongengaged tissue in a medical procedure. This, in turn, providesadditional support for engaged structures by enlarging the overallfoot-print of the center portion 2, in situ, offering a greaterdistribution of forces.

FIGS. 7 and 8 show an alternative embodiment of a fabricated component15, 15′ produced in accordance with the present invention. In thisconfiguration, the strands 3 ₁, 3 ₂, 3 ₃, 3 ₄, 3 ₅ shown in FIGS. 1 and5 have been provided with a plurality of knots 16. The fabricatedcomponent 15 of FIG. 7 is otherwise substantially similar to thefabricated component 1 shown in FIG. 1, and the fabricated component 15′shown in FIG. 8 is otherwise substantially similar to the fabricatedcomponent 1′ shown in FIG. 5. An embodiment similar to the fabricatedcomponent 1″ shown in FIG. 6 can also be produced, but is presentlyconsidered to be less preferred.

The knots 16 cause limited separation between the strands 3 ₁, 3 ₂, 3 ₃,3 ₄, 3 ₅ while allowing at least portions of the strands 3 ₁, 3 ₂, 3 ₃,3 ₄, 3 ₅ to remain in contact with one another. Limited separation ofthe strands 3 ₁, 3 ₂, 3 ₃, 3 ₄, 3 ₅ can provide additional stressdistribution along the center portion 2 of the fabricated component 15,15′, for example, to provide additional stress distribution alongengaged tissue in a medical procedure. This can then provide additionalsupport for engaged structures by enlarging the overall foot-print ofthe center portion 2, in situ, offering a greater distribution offorces. The knots 16 are preferably staggered along the lengths of thestrands 3 ₁, 3 ₂, 3 ₃, 3 ₄, 3 ₅, as shown, so that the knots 16 do notcoincide and so that there is no unwanted bulk that might impede passageof the fabricated component 15, 15′ through a narrow passage, such aspunctures of the skin and subcutaneous passageways in medicalapplications.

Fabrication of the components 15, 15′ shown in FIGS. 7 and 8 will now bedescribed with reference to FIGS. 9 and 10. Referring to FIG. 9, astrand 17 similar to the strand 8 shown in FIG. 2 is provided with theknots 16, at desired locations along the strand 17, and which can varyto suit a particular application. This will include the locations of theknots 16, as well as the number of knots 16 formed along the strand 17.The knots 16 can either be uniform in size, and in overallconfiguration, or varied in size and in overall configuration, as isdesired for a particular application. Typically, single throw knots willsuffice for this, although multiple throw knots, thickened knots (e.g.,a “figure-eight” configuration), or woven or braided knots can also beused.

Referring next to FIG. 10, central portions 18 of the strand 17 areagain initially formed into a plurality of loops or coils 10 _(n),similar to the coils 10 _(n) illustrated in FIG. 3. The knots 16 arepreferably located along the length of the strand 17 so that the knots16 will be located along the strands 3 ₁, 3 ₂, 3 ₃, 3 ₄, 3 ₅ of thecenter portion 2 of the fabricated component 15, 15′ followingcompletion of the resulting assembly. Each of the gathering points 5 a,5 b is then similarly formed to complete the fabrication of a closedlooped component 15 or an open looped component 15′, as desired. As aresult of the foregoing, the knots 16 will typically be located as isshown in FIGS. 7 and 8, and each knot 16 can serve to separate portionsof the strands 3 ₁, 3 ₂, 3 ₃, 3 ₄, 3 ₅ from one another while otherportions of the strands 3 ₁, 3 ₂, 3 ₃, 3 ₄, 3 ₅ remain in contact withone another.

FIGS. 11 and 12 show a further alternative embodiment of a fabricatedcomponent 20, 20′ produced in accordance with the present invention. Inthis configuration, a series of eight strands 3 ₁, 3 ₂, 3 ₃, 3 ₄, 3 ₅, 3₆, 3 ₇, 3 ₈ have been organized into two separate groups 21, 22. Anynumber of strands 3 _(n) can be combined into any of a number ofseparate groups, as is preferred for a particular application. Also inthis configuration, the strands 3 ₁, 3 ₂, 3 ₃, 3 ₄ of the group 21 havebeen twisted together and the strands 3 ₅, 3 ₆, 3 ₇, 3 ₈ of the group 22have separately been twisted together. It would also be possible, ifdesired, for all of the strands to be twisted together to form a singlegroup. Twisting of the strands operates to further increase the overallbulk of the resulting assembly, providing another way of distributingstress along the center portion 2 of the fabricated component. Thefabricated component 20 shown in FIG. 11 is otherwise substantiallysimilar to the fabricated components 1, 15 shown in FIGS. 1 and 7, andthe fabricated component 20′ shown in FIG. 12 is otherwise substantiallysimilar to the fabricated components 1′, 15′ shown in FIGS. and 8. Anembodiment similar to the fabricated component 1″ shown in FIG. 6 canalso be produced, but is presently considered to be less preferred.

Fabrication of the components 20, 20′ shown in FIGS. 11 and 12 will nowbe described with reference to FIGS. 13 and 14. Referring to FIG. 13, astrand similar to the strand 8 shown in FIG. 2 is initially formed intoa plurality of loops or coils 10 _(n), similar to the coils 10 _(n)shown in FIG. 3. A first gathering point 25 is then formed by passingone of the opposing ends 6 of the strand 8 around the bundled coils 10_(n), and then passing the end 6 of the strand 8 through the resultingthrow, to hold the coils 10 _(n) together. The coils 10 _(n) are thendivided into at least two groups, in the illustrated example, the groups27 and 28.

Referring next to FIG. 14, the remaining free end 7 of the strand 8 ispassed through free ends 30 of the coils 10 _(n) in the first group 27,and is then passed through free ends 30 of the coils 10 _(n) in thesecond group 28. A second gathering point 31 is then formed by joiningthe ends 30 of the coils 10 _(n) in the first group 27 and the ends 30of the coils 10 _(n) in the second group 28. As previously described,the gathering point 31 can be formed by passing the end 7 of the strand8 through the throw formed when joining the ends 30 of the coils 10 _(n)in the first group 27 and the ends 30 of the coils 10 _(n) in the secondgroup 28, to hold the several coils 10 _(n) together. Suitable formationof the second gathering point 31 results in fabrication of the component20 shown in FIG. 11 or the component 20′ shown in FIG. 12.

FIG. 15 shows a further alternative embodiment of a fabricated component20″ produced in accordance with the present invention. In thisconfiguration, a series of coiled loops 10 _(n) have been organized intotwo separate groups 27, 28, similar to the previously describedfabrication of the components 20, 20′ shown in FIGS. 13 and 14. Anynumber of strands 3 _(n) can be combined into any of a number ofseparate groups, as preferred for a particular application. In theconfiguration selected for illustration, the strands 3 _(n) of thegroups 27, 28 have not been twisted together. It would also be possiblefor some, or all of the strands and groups of strands to be twistedtogether as previously described, if desired.

A first gathering point 25 is formed, as previously described, bypassing one of the opposing ends 6 of the strand 8 forming the component20″ around the bundled coils 10 _(n), and by then passing the end 6 ofthe strand 8 through the resulting throw to hold the coils 10 _(n)together. The remaining free end 7 of the strand 8 is first passedaround the free ends 30 of the coils 10 _(n) in the first group 27, andis passed through the resulting throw, causing the throw to contractinto a closed loop structure which closely surrounds the engaged coils10 _(n) at a first gathering point 31′. A second gathering point 31′ isthen formed by passing the free end 7 of the strand 8 around the freeends 30 of the coils 10 _(n) in the remaining group 28, and through theresulting throw, to again cause the throw to contract into a closed loopstructure which closely surrounds the engaged coils 10 _(n), and tocomplete the fabrication of the component 20″. As a further alternative,the resulting throws can be knotted, similar to the knots 12′ used tofabricate the components 1′, 1″, 15′, 20′, to form a component 20″having the open loop structures which are presently considered preferredto facilitate sliding of the plural strands 3 _(n) relative to oneanother and relative to the gathering points 25, 31′.

The gathering points 31′ are preferably staggered so they do notcoincide and so that there is no unwanted bulk that might impede passageof the fabricated component 20″ through a narrow passage, such aspunctures of the skin and subcutaneous passageways in medicalapplications. For this reason, the size of the coils 10 _(n) which formthe group 27 preferably differs from the size of the coils 10 _(n) whichform the group 28.

FIG. 16 shows a further alternative embodiment of a fabricated component35 produced in accordance with the present invention, having pluralgathering points at each of the opposing ends of the center portion 2.The component 35 can be fabricated using a strand of material which issimilar to the strand 8 used to form other embodiments, but having anincreased length. One end of the strand 8 is used to form a group 27 ofbundled coils 10 _(n), similar to the coils 10, used to form thecomponents 1, 1′, 1″ shown in FIGS. 3 to 6. Two gathering points 5 a, 5b are then formed, for example, by passing opposing portions of thestrand 8 around the bundle of coils 10, forming the group 27, in eachcase forming a throw, and by then passing available portions of thestrand 8 through each of the resulting throws to hold the coils 10 _(n),together, as previously described. The remainder of the strand 8 canthen be used to form another group 28 of bundled coils 10 _(n), similarto the group 27. Two additional gathering points 5 a′, 5 b′ can then beformed, for example, by passing opposing portions of the strand 8 aroundthe bundle of coils 10 _(n) forming the group 28, in each case forming athrow, and by then passing available portions of the strand 8 througheach of the resulting throws to hold the coils 10 _(n) together andcomplete the fabrication of the component 35. The gathering points 5 a,5 a′ and the gathering points 5 b, 5 b′ are preferably staggeredrelative to one another so the various gathering points do not coincideand so that there is no unwanted bulk that might impede passage of thefabricated component 35 through a narrow passage, such as punctures ofthe skin and subcutaneous passageways in medical applications.

Any number of strands 3 _(n) can be combined into any of a number ofseparate groups, as is preferred for a particular application. Inaddition, and as a further alternative, separate strands of material canbe passed around the bundles of coils 10 _(n) to hold the coils 10 _(n)together, which can be used to develop free ends 6, 7 having a pluralityof strands, if desired. Free ends 6, 7 having a plurality of strands canalso be developed using a strand 8 formed from multiple strands, aspreviously described. Also, while the groups 27, 28 of strands 3 _(n)have not been twisted together in the configuration illustrated, itwould be possible for some, or all of the strands and groups of strandsto be twisted together as previously described, if desired.

A series of single throw ties can be used to form the gathering points 5a, 5 b of the components 1, 1′, 15, 15′, the gathering points 25, 25′and 31, 31′ of the components 20, 20′, 20″, and the gathering points 5a, 5 a′ and 5 b, 5 b′ of the component 35, if desired, and wouldpreferably be used to form the knots 12′ of the component 1″, or tofurther secure the knots 12, 12′ and prevent the gathering points fromunraveling. Multiple throws, preferably forming square knots, arecurrently considered to be particularly useful.

Because the various fabricated components which have previously beendescribed are particularly well suited to uses supporting subcutaneoustissue, muscle and organs, or other structures which may be hidden fromview, certain uses could benefit from structures which would help locatethe component during use and when hidden from view. This can beaccomplished by providing the fabricated component with features thatcan be located when hidden from view, and which can be referenced toother structures that may be hidden from view, for example, to bone,teeth or soft tissues in surgical applications.

For example, the knots 16 of the components 15, 15′ shown in FIGS. 7 and8 can be replaced with beads formed of a material that can be suitablydetected. As an alternative, beads 32, 33 formed of a detectablematerial can additionally be positioned as is shown in FIGS. 7 and 8.The beads 32 are positioned between adjacent knots 16, and are retainedin desired position by the knots 16. The beads 33 are positionedadjacent to and outboard from the knots 12, 12′, and can be retained inposition by suitably knotting the free ends 6, 7 of the strand 8 overthe beads 33. As a further alternative, cylinders 34 formed of adetectable material can be used, as is shown, for example, in FIGS. 11and 12, adjacent to and outboard from the knots 25, 31 or the knots 25′,31′. The beads 33 and the cylinders 34 can be located on both sides ofthe center portion 2, as is shown in the drawings, or can be located oneither of the two sides, if preferred for a given application, forexample, to locate the left or right side of the component. The beads32, 33 and the cylinders 34 can be retained in position by knots, aspreviously described, or can be retained in position using an adhesive,or mechanically, for example, by crimping.

The beads 32, 33, and the cylinders 34, can be formed of any materialwhich can be appropriately detected by equipment suited to the use beingundertaken with the fabricated component. For example, metallicstructures or other materials which are opaque to x-ray equipment orultrasound equipment can be used. Stainless steel would be well suitedto surgical applications. However, any material suitable to detection byan appropriate technology can be used to achieve a similar result. Thebeads 32, 33 can be spherical or oval, and the cylinders 34 can beshaped, as may be needed to provide a suitably detectable structure.Sizes on the order of 21 to 23 gage, or 1 mm in diameter or length, arepresently considered to be preferred.

Examples of some applications using the fabricated components which havepreviously been described will now be illustrated. These illustrativeapplications are described in the context of a medical procedure of thetype described, for example, in U.S. patent application Ser. No.12/452,743 and in U.S. patent application Ser. No. 12/384,326, thesubject matter of which is incorporated by reference as if fully setforth herein. It is to be understood, however, that the fabricatedcomponents of the present invention can also be used to perform othermedical procedures, as well as other non-medical procedures suited to aparticular application. The fabricated components of the presentinvention can also be used in place of a conventional suture, to performany of a variety of medical procedures, with or without the placement ofa needle at either or both of the ends 6, 7 of the fabricated component,as is desired for a given application.

In a first illustrative example, and referring to FIGS. 17, 18 and 19,the components 1′, 15′, 20′ respectively illustrated in FIGS. 5, 8 and12 are shown in use performing a mid face surgical application in whichthe malar fat pad 40 has been engaged by a suture-supporting sling 41.The sling 41 is positioned subcutaneously, under the malar fat pad 40,and is engaged and anchored at 42, for example, in or above the bone orperiosteum in the zygomatic arch 43. It is to be understood that whilethe opposing ends 6, 7 of the components 1′, 15′, 20′ have been anchoredin the same location, the ends 6, 7 can also be anchored at separatelocations, if preferred.

In another illustrative example and referring to FIG. 20, the component1′ illustrated in FIG. 5 is shown in use for the suspension of a vessel44, or other organ, using a sling 41 developed by multiple strands 3 ₁,3 ₂, 3 ₃, 3 ₄, 3 ₅ of the component 1′, appropriately supported by theends 6, 7 of the component 1′, which is schematically illustrated by thevectors F.

It should be noted that for purposes of illustration, the multiplestrands 3 ₁, 3 ₂, 3 ₃, 3 ₄, 3 ₅ have been separated to more clearlyillustrate the structures of the components being shown in FIGS. 17 to20. In practice, however, the strands 3 ₁, 3 ₂, 3 ₃, 3 ₄, 3 ₅ of suchcomponents would be bunched together, between their opposing gatheringpoints, so that at least portions of the strands 3 ₁, 3 ₂, 3 ₃, 3 ₄, 3 ₅are in contact with one another.

In use, the multiple strands 3 ₁, 3 ₂, 3 ₃, 3 ₄, 3 ₅ of the sling 41 actas a cushion for protecting the engaged structure from high stressdamage or erosion. For strands 3 ₁, 3 ₂, 3 ₃, 3 ₄, 3 ₅ capable ofsliding within the gathering points 5 a, 5 b of the component, theplural strands will remain equally taut so the load will be evenlydistributed. The thickened bundle presented by the plural strands 3 ₁, 3₂, 3 ₃, 3 ₄, 3 ₅ eliminates the need to use larger diameter strands toachieve a similar result, which could otherwise introduce anunacceptable stiffness to the positioned sling 41.

In some applications, there can be a need to adjust a component whichhas been positioned, subsequent to placement of the component. Forexample, in conjunction with the previously described surgicalprocedures, there is the potential for the positioned component tomigrate, or for there to be a change in the condition of the tissue,muscle or organ engaged by the component, leading to the potential forthere to be an erosion through the engaged tissue, muscle or organ. Insuch cases, the ability to adjust the component after the component hasbeen subcutaneously placed would avoid the need for open surgery toremove or replace the component.

Such adjustment is preferably achieved in accordance with the presentinvention by adjusting the length of one or more of the strands 3 _(n)of the positioned component. For example, FIG. 21 schematically shows amass 45 supported by the strands 3 _(n) of the center portion 2 of thecomponent 1 shown in FIG. 1. As an example, the mass 45 can representsubcutaneous malar fat in a face lift procedure, supported by anchoringpoints 42 a, 42 b formed at spaced locations along the bone orperiosteum in the zygomatic arch. FIG. 22 shows a corresponding diagramillustrating the forces involved. The center portion 2 has an initiallength L₁ and is spaced from the anchoring points 42 a, 42 b by adistance A, yielding an initial lift height H₁.

Adjustment of the assembly is accomplished by changing the length of thecenter portion 2. To this end, and referring to FIGS. 23 and 24, whichcorrespond to the FIGS. 21 and 22, respectively, at least one of thestrands 3 _(n) has been shortened.

In the illustrated example, the strand 3 ₄ has been shortened by cuttingthe strand 3 ₄ and by suitably connecting the cut ends 47, 48 of thestrand 3 ₄ at a different location, shown at 49. This can be done byknotting the free ends, by using a separate tie to reconnect the freeends, or by using a separate band or clip to join the free ends.Additional shortening of the strand 3 ₄ can be accomplished by removinga portion of the cut strand, prior to reconnection. Adjustments such asthe foregoing can be performed by severing a single strand, or bysevering plural strands, if desired. If plural strands are to beadjusted, a separate connection 49 can be associated with each of thestrands, or a single connection 49 can be associated with multiplestrands.

It is also possible to shorten the strand 3 ₄ without cutting the strand3 ₄, but to instead knot or otherwise gather the strand 3 ₄ at thelocation 49, or to use a separate tie, band or clip to engage the strand3 ₄ at the location 49. As an example, and referring to FIGS. 25 and 26,the strand 50 has not been cut, but has instead been gathered to form aloop 51. Referring to FIG. 25, a separate tie 52 is placed around, or inthe alternative, woven through the exposed loop 51. Referring next toFIG. 26, the ends 53 of the tie 52 are preferably knotted, braided,banded or clipped at the location 54 to prevent the loop 51 fromunraveling and to maintain the shortened length established for thestrand 50. As an alternative, the strand 50 can be joined at otherlocations along the loop 51, for example, along the upper portions 55.Among other applications, such configurations can be useful insituations where cut ends would be too short to effectively receive aknot, but would be of a sufficient length to receive the tie 52,including both medical and non-medical applications.

Any strands 3 _(n) which have not been cut or otherwise shortened willthen preferably slip through the gathering points 5 a, 5 b (or thegathering points 25, 31) to equalize the resulting assembly. To be notedis that for procedures such as the above mentioned face lift procedures,the foregoing operations can be performed on a subcutaneously locatedcomponent, by drawing the strand or plural strands to be adjustedthrough a puncture point at or near the location 49, avoiding the needfor open surgery to remove or replace the component.

As a result of the foregoing operations, and referring to FIGS. 23 and24, the center portion 2 will have a reduced length L₂. Because thecenter portion 2 will remain spaced from the anchoring points 42 a, 42 bby the distance A, this will yield a final lift height H₂ which isshorter than the initial lift height H₁. Such adjustment can be used tosuitably reposition the supported mass 45, for example, to raise themalar fat in the foregoing example of a face lift procedure.

Because the strands 3 _(n) are permitted to slip within the gatheringpoints 5 a, 5 b and 25, 31, a mechanical reduction (1:n) will resultfrom shortening of the strands. This yields greater sensitivity toadjustment, increasing the precision in control of the change in lengthand facilitating lift of the supported mass 45. As an example, for thearray of five strands 3 ₁, 3 ₂, 3 ₃, 3 ₄, 3 ₅ previously discussed,shortening one of the strands will yield a 1:5 reduction for theresulting array. This, in turn, yields a corresponding increase in theworking length of the shortened strand, allowing a knot or othersuitable connection to be more easily formed. Such effects can be evenfurther amplified by adjusting plural strands forming the array and/orby increasing the number (n) of strands associated with the array, ifdesired for a particular application. To accommodate such effects, thecenter portion of a fabricated component is preferably initially formedto be longer than the structure to be supported so that in the event thecenter portion is later to be shortened, a surplus working length willbe available for shortening of the strands 3 _(n) without interferingwith the supported structure, for purposes of yielding a smooth and moreeven result.

Adjustment procedures such as the foregoing, including adjustmentsinvolving cut strands or looped strands, can be used to adjust thepreviously described fabricated components, as well as other desiredcomponents, including conventional sutures used in various medicalprocedures and surgical applications. This can include the adjustment ofexposed components, as well as the adjustment of unexposed componentssuch as subcutaneously located sutures and the like. As an example, asubcutaneously positioned suture can be adjusted by engaging the suturethrough a puncture point or a small opening, and by pulling the suturethrough the puncture point, exposing the suture for adjustment aspreviously described. The adjusted suture can then be pushed through theopening which, because of its small size, can easily heal in the normalcourse. Such adjustment can be used to later correct a surgicalprocedure, either to achieve an improved result or to provide forchanges occurring following the surgical procedure due, for example, tomigration or aging of the engaged tissues or the previously positionedcomponent, without the need to replace the original component or for anyopen surgery.

It will be understood that while the present invention has beendescribed based on specific embodiments incorporating specified parts,the present invention further encompasses all enabled equivalents of theparts described, and that various changes in the details, materials andarrangement of parts which have been herein described and illustrated inorder to explain the nature of this invention may be made by thoseskilled in the art within the principle and scope of the invention asexpressed in the following claims.

We claim:
 1. A sling for providing structural support to a mass,comprising: a central strand section of material forming multiple loopsto support the mass, a first bundle of the multiple loops passingthrough a first gathering point encircling the first bundle, and asecond bundle of the multiple loops passing through a second gatheringpoint encircling the second bundle, the multiple loops freely extendingbetween the first and second gathering points; a first end strandsection of material forming a first free end of the sling and beingconnected to the central strand section; and a second end strand sectionof material forming a second free end of the sling and being connectedto the central strand section, wherein opposing regions of the multipleloops of the central strand section are provided with the first andsecond gathering points, respectively; the first gathering point beingformed by passing a first end of the central strand section or an end ofthe first end strand section around the first bundle of the multipleloops; and the second gathering point being formed by passing anopposing second end of the central strand section or an end of thesecond end strand section around the second bundle of the multipleloops.
 2. The sling of claim 1, wherein the multiple loops are freelyslidable around the first and second gathering points to slip relativeto one another.
 3. The sling of claim 1, wherein at least one of thefirst and second gathering points comprises an end of the central strandsection looping around the first or second bundle, respectively, therebyforming a throw, and passing through the throw.
 4. The sling of claim 1,wherein the central strand section, the first end strand section and thesecond end strand section are formed from a single strand of material.5. The sling of claim 1, wherein the central strand section, the firstend strand section and the second end strand section are formed from aplurality of individual strands of material.
 6. The sling of claim 1,wherein at least one of the first and second gathering points is formedfrom the first end strand section.
 7. The sling of claim 1, wherein thecentral strand section, the first end strand section and the second endstrand section are formed of a suture material useful in a medicalprocedure.
 8. The sling of claim 1, further comprising an adhesiveapplied to at least one of the first and second gathering points.
 9. Thesling of claim 1, further comprising a marker coupled with the sling forlocating a portion of the sling which is at least partially hidden fromview.
 10. The sling of claim 9, wherein the marker is a bead or acylinder coupled with the strands of the sling.
 11. The sling of claim9, wherein the marker is a bead or a cylinder coupled with at least onefree end of the sling.
 12. The sling of claim 9, wherein the marker isformed of a material that can be detected by x-ray equipment orultrasound equipment.
 13. The sling of claim 1, wherein at least one ofthe first and second gathering points is formed from the second endstrand section.
 14. The sling of claim 1, wherein at least one of thefirst and second gathering points is formed from the central strandsection.
 15. The sling of claim 1, wherein the first end strand sectionforms the first gathering point and the second end strand section formsthe second gathering point.
 16. A method for supporting a masscomprising: positioning a sling subcutaneously, the sling comprising: acentral strand section of material forming multiple loops to support themass, a first bundle of the multiple loops passing through a firstgathering point encircling the first bundle, and a second bundle of themultiple loops passing through a second gathering point encircling thesecond bundle, the multiple loops freely extending between the first andsecond gathering points; a first end strand section of material forminga first free end of the sling and being connected to the central strandsection; and a second end strand section of material forming a secondfree end of the sling and being connected to the central strand section,wherein opposing regions of the multiple loops of the central strandsection are provided with the first and second gathering points,respectively; the first gathering point being formed by passing a firstend of the central strand section or an end of the first end strandsection around the first bundle of the multiple loops; and the secondgathering point being formed by passing an opposing second end of thecentral strand section or an end of the second end strand section aroundthe second bundle of the multiple loops; engaging the mass with thecentral strand section; and coupling the first and second free ends torespective anchoring points.
 17. The method of claim 16, furthercomprising the step of shortening at least one of the plurality of loopsextending between the first and second gathering points, therebyshortening the central strand section.
 18. The method of claim 16,wherein the coupling step comprises coupling the first and second freeends to different anchoring points.
 19. The method of claim 16, whereinthe coupling step comprises coupling the first free end to an anchoringpoint and coupling the second free end to the same anchoring point. 20.The method of claim 16, further comprising the steps of coupling amarker with the sling and locating a portion of the subcutaneous slingrelative to the mass by detecting the marker.